The U.S. Food and Drug Administration (FDA) announced it cleared Pfizer’s antiviral pill, Paxlovid, to treat COVID-19.
Paxlovid can be used for the treatment of mild-to-moderate COVID-19 in adults and paediatric patients (12 years of age and older weighing at least 40 kg [88 lbs]) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalisation or death.
This is the first pill authorised to treat the virus in the midst of infection.
“Today’s authorization of Paxlovid represents another tremendous example of how science will help us ultimately defeat this pandemic, which, even two years in, continues to disrupt and devastate lives across the world. This breakthrough therapy, which has been shown to significantly reduce hospitalizations and deaths and can be taken at home, will change the way we treat COVID-19, and hopefully help reduce some of the significant pressures facing our healthcare and hospital systems,” said Albert Bourla, Chairman and CEO Pfizer.
“Pfizer stands ready to begin delivery in the U.S. immediately to help get Paxlovid into the hands of appropriate patients as quickly as possible.”
Pfizer said studies showed that Paxlovid reduced risk of hospitalisation or death by 89% (within three days of symptom onset) and 88% (within five days of symptom onset) compared to placebo.